Appeal to Minister
60.—(1) Any person who is aggrieved by —(a)
any refusal of the Director‑General to grant any approval or permit required under this Act;[Act 11 of 2023 wef 01/05/2023]
(b)
any decision of the Director‑General to suspend or revoke any such approval or permit; or[Act 11 of 2023 wef 01/05/2023]
(c)
any order of the Director‑General for the cessation of any activity carried out on any facility, the destruction of any biological agent, inactivated biological agent or toxin at any facility, the decontamination of any facility or the closure or cordoning off of any facility,[Act 11 of 2023 wef 01/05/2023]
may appeal to the Minister in writing within such time as may be prescribed.
(2) The decision of the Minister is final.
(3) Despite any appeal, an order made by the Director‑General for the cessation of any activity, or the closure or cordoning off of any facility, takes effect from the date specified in the order, unless the Minister otherwise directs.[Act 11 of 2023 wef 01/05/2023]
General exemption
61. The Minister may, either permanently or for such period as the Minister may think fit, exempt any person or premises or any class of persons or premises from all or any of the provisions of this Act.
Amendment of Schedules
62. The Minister may at any time, by order in the Gazette, amend any Schedule.
Regulations
63.—(1) The Minister may make regulations for carrying out the purposes and provisions of this Act.
(2) Without limiting subsection (1), the Minister may make regulations for or with respect to all or any of the following matters:(a)
the regulation of the possession, storage, use, import, transfer, transportation and disposal of scheduled biological agents, inactivated scheduled biological agents and Fifth Schedule toxins, including —(i)
the imposition of duties and obligations of persons who possess, store, use, import, transfer, transport or dispose of such biological agents, inactivated biological agents and toxins; and
(ii)
the measures, practices, procedures, processes and standards to be adopted and implemented in the possession, storage, use, import, transfer, transportation and disposal of such biological agents, inactivated biological agents and toxins;
(b)
the regulation of the design and structural requirements of facilities;
(c)
the qualifications of persons controlling, managing or carrying out the storage or disposal of, or activities involving, any scheduled biological agent, inactivated scheduled biological agent or Fifth Schedule toxin at any facility;
(d)
the measures to be adopted and implemented for dealing with and investigating into any adverse incident and the procedures for the reporting of such adverse incident to the Director‑General;[Act 11 of 2023 wef 01/05/2023]
(e)
the duties and obligations of operators, biosafety committees, biosafety co‑ordinators and staff of facilities (in addition to the duties and obligations of such persons specified in this Act);
(f)
the procedures of biosafety committees;
(g)
the prescribing of fees payable for the purposes of this Act;
(h)
such matters as may be required by this Act to be prescribed;
(i)
such other matter as the Minister thinks necessary for the administration and enforcement of this Act.
(3) The Minister may, in making any regulations under this section —(a)
provide that where there has been any contravention of any provision thereof, the Director‑General may, as may be appropriate, order —(i)
the immediate cessation of any activity involving any scheduled biological agent, inactivated scheduled biological agent or Fifth Schedule toxin;
(ii)
the destruction of any scheduled biological agent, inactivated scheduled biological agent or Fifth Schedule toxin;
(iii)
the decontamination of any facility;
(iv)
the closure or cordoning off of any facility until such time as the Director‑General is satisfied that the facility may safely resume operation; and
(v)
that any person who is or was at any facility (whether as a member of the staff of the facility or otherwise) and who may be or may have been exposed to any scheduled biological agent, inactivated scheduled biological agent or Fifth Schedule toxin at the facility should —(A)
undergo such medical examination and medical treatment at such place or hospital as the Director‑General may specify in the order; or
(B)
be quarantined at such place and for such period as the Director‑General may specify in the order; and[Act 11 of 2023 wef 01/05/2023]
(b)
provide that a contravention of any provision of the regulations or an order referred to in paragraph (a) made under the regulations shall be an offence punishable —(i)
in relation to or in connection with any First Schedule (Part 1) biological agent, Third Schedule biological agent or Fourth Schedule biological agent, with a fine not exceeding $10,000 or with imprisonment for a term not exceeding 12 months or with both; and
(ii)
in relation to or in connection with any First Schedule (Part 2) biological agent, Second Schedule biological agent or Fifth Schedule toxin, with a fine not exceeding $100,000 or with imprisonment for a term not exceeding 10 years or with both.
(4) In this section —“inactivated scheduled biological agent” means a First Schedule biological agent, a Second Schedule biological agent, a Third Schedule biological agent or a Fourth Schedule biological agent that has been inactivated;
“scheduled biological agent” means a First Schedule biological agent, a Second Schedule biological agent, a Third Schedule biological agent or a Fourth Schedule biological agent.
